Etorix® is the preparation of Etoricoxib. It is a nonsteroidal anti- inflammatory drug

(NSAID) that exhibits anti-inflammatory, analgesic and antipyretic activities in

animal models. It is a potent, orally active, highly selective cyclooxygenase-2

(COX-2) inhibitor within and above the clinical dose range. COX-2 has been

shown to be primarily responsible for the synthesis of prostanoid mediators of

pain, inflammation and fever. Selective inhibition of COX-2 by Etoricoxib

decreases these clinical signs and symptoms with decreased GI toxicity and

without effects on platelet function.

INDICATIONS

Pain and inflammation in osteoarthritis, in rheumatoid arthritis and in other chronic

musculoskeletal disorders, acute gout, pain of dysmenorrhoea and pain following

dental surgery.

DOSAGE AND ADMINISTRATION

Adult and adolescent over 16 years:

•In case of osteoarthritis, dysmenorrhoea, chronic musculoskeletal

 disorders: 60 mg once daily

•In case of rheumatoid arthritis: 90 mg once daily

•In case of pain following dental surgery & acute gout: 120 mg once daily

Safety and effectiveness of Etoricoxib in paediatric patients have not been

established.

CONTRAINDICATIONS

It is contra-indicated in inflammatory bowel disease, severe congestive heart

failure.

USE IN PREGNANCY AND LACTATION

As with other drugs known to inhibit prostaglandin synthesis, use of it should be

avoided in late pregnancy because it may cause premature closure of the ductus

arteriosus. It should be used during the first two trimesters of pregnancy only if the

potential benefit justifies the potential risk to the foetus. It is not known whether this

drug is excreted in human milk.

SIDE-EFFECTS

Side-effects of Etoricoxib are dry mouth, taste disturbance, mouth ulcers,

flatulence, constipation, appetite and weight changes, chest pain, fatigue,

paraesthesia, influenza-like syndrome, myalgia.

PRECAUTIONS

In patients with advanced renal disease, treatment with it is not recommended.

Clinical experience in patients with estimated creatinine clearance of <30 mL / min

is very limited. If therapy with it must be initiated in such patients, close monitoring

of the patient's renal function is advisable. Caution should be used when initiating

treatment with it in patients with considerable dehydration. It is advisable to

rehydrate patients prior to starting therapy with it. The possibility of fluid retention,

oedema or hypertension should be taken into consideration when it is used in

patients with pre-existing oedema, hypertension or heart failure. Independent of

treatment, patients with a prior history of GI perforation, ulcers and bleeding

(PUB) and patients greater than 65 years of age are known to be at a higher risk

for a PUB. A patient, with symptoms and/or signs suggesting liver dysfunction or

in whom an abnormal liver function test has occurred, should be evaluated for

persistently abnormal liver function tests. If persistently abnormal liver function

tests (three times the upper limit of normal) are detected, it should be

discontinued. It should be used with caution in patients who have previously

experienced acute asthmatic attacks, urticaria or rhinitis, which were precipitated

by salicylates or non- selective cyclooxygenase inhibitors. It may mask fever, which

is a sign of infection. The physician should be aware of this when using it in patients

being treated for infection.

PHARMACEUTICAL PRECAUTION

Do not store above 30 °C temperature. Keep away from light and wet place. Keep

out of reach of children.

PACKAGING

Etorix® 60 tablet : Box containing 5 strips of 10 tablets each. Each film coated

tablet contains Etoricoxib INN 60 mg.

Etorix® 90 tablet : Box containing 4 strips of 10 tablets each. Each film coated

tablet contains Etoricoxib INN 90 mg.

Etorix® 120 tablet : Box containing 3 strips of 10 tablets each. Each film coated

tablet contains Etoricoxib INN 120 mg.